{"product_id":"labelling-and-medical-device-file-pack","title":"Labelling \u0026 Medical Device File Pack","description":"\u003cp\u003eTeams often reach submissions, audits, or commercial release with weak file structure, inconsistent IFUs, and no reusable template set for notices and device-file control. This pack gives you a cross-jurisdiction labelling and device-file starting point so the commercial and regulatory document set is structured from the beginning. That means less time spent rebuilding documents from scratch and a stronger line of evidence when the process is sampled under audit.\u003c\/p\u003e\u003ch3\u003eWhat's included\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eISO 13485 IFU Template.docx\u003c\/li\u003e\n\u003cli\u003eAdvisory Notice Templates.docx\u003c\/li\u003e\n\u003cli\u003eMedical Device File Template.docx\u003c\/li\u003e\n\u003cli\u003eMDF Index Workbook.xlsx\u003c\/li\u003e\n\u003cli\u003eEU MDR IFU Template.docx\u003c\/li\u003e\n\u003cli\u003eFDA IFU Template.docx\u003c\/li\u003e\n\u003cli\u003eField Action Notice Template.docx\u003c\/li\u003e\n\u003cli\u003eImplementation Guide.pdf\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eBest suited to:\u003c\/strong\u003e Manufacturer, Distributor, Regulatory consultant, and Quality manager.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eUseful in audit situations where you need to:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eShow a structured labelling and medical device file control process during ISO 13485 certification, surveillance, supplier, or internal audits.\u003c\/li\u003e\n\u003cli\u003eSupport FDA inspections with controlled records, traceability, and process evidence related to labelling and medical device file control.\u003c\/li\u003e\n\u003cli\u003eSupport EU MDR technical documentation or quality-system reviews where labelling and medical device file control records need to be complete, controlled, and consistent.\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eUse this pack to tighten execution, strengthen evidence, and make this part of your ISO 13485 system easier to defend under audit.\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":47258390593730,"sku":"Labelling \u0026 Medical Device File Pack","price":399.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/Firefly_GeminiFlash_Createasquarepremiumproductthumbnailfor_Labelling_MedicalDeviceFilePack_.74305.png?v=1773431177","url":"https:\/\/isocloudconsulting.com\/products\/labelling-and-medical-device-file-pack","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}